BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇹🇭 Thailand

    Palm Care Blue Nitrile Examination Gloves Powder Free

    K Number: K202384 · Decision Dec 2, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    2
    Review Days
    104

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    Basic Information

    Device Name
    Palm Care Blue Nitrile Examination Gloves Powder Free
    K Number
    K202384
    Device Class
    FDA class 1
    Clearance Type
    Abbreviated
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hi-Care Thai Gloves Co. , Ltd.
    Date Received
    August 20, 2020
    Decision Date
    December 2, 2020
    Product Code
    LZA
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LZA Polymer Patient Examination Glove

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    Other Clearances by Hi-Care Thai Gloves Co. , Ltd.

    K Number Device Name
    K202377 Palm Care Latex Examination Powder Free Gloves